ID

32934

Description

Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00974090

Link

https://clinicaltrials.gov/show/NCT00974090

Keywords

Versions (2)
  1. 11/20/18 11/20/18 -
  2. 11/21/18 11/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00974090

English

Eligibility Type 2 Diabetes Mellitus NCT00974090

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are 20 - 75 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Description

Diet therapy | Exercise Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0011849
patients whose hba1c is between 7.0% and 10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
patients who took sulfonylurea for diabetes over 12 weeks before administration of investigational drug
Description

Sulfonylurea

Data type

boolean

Alias
UMLS CUI [1]
C0038766
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Description

Antidiabetics Illicit Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc)
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreatic Insufficiency | Secondary diabetes mellitus | Cushing's disease | Acromegaly

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0030293
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0221406
UMLS CUI [5]
C0001206
patients with class iii/iv heart failure symptoms according to nyha functional classification
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
patients who are gastrointestinal disorder (diarrhea, vomiting)
Description

Gastrointestinal Disease | Diarrhea | Vomiting

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0011991
UMLS CUI [3]
C0042963
patients with serious diabetic complications
Description

Complications of Diabetes Mellitus Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205404
patients who are the excessive alcohol addicts
Description

Alcohol addiction Excessive

Data type

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0442802
patients with severe hepatic disorder or severe renal disorder
Description

Liver disease Severe | Kidney Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Description

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1299582
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00974090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients who are 20 - 75 years old
boolean
C0001779 (UMLS CUI [1])
Diet therapy | Exercise Diabetes Mellitus
Item
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
patients whose hba1c is between 7.0% and 10.0%
boolean
C0474680 (UMLS CUI [1])
Sulfonylurea
Item
patients who took sulfonylurea for diabetes over 12 weeks before administration of investigational drug
boolean
C0038766 (UMLS CUI [1])
Antidiabetics Illicit Absent
Item
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
boolean
C0935929 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreatic Insufficiency | Secondary diabetes mellitus | Cushing's disease | Acromegaly
Item
patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc)
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0030293 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
C0221406 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
Heart failure New York Heart Association Classification
Item
patients with class iii/iv heart failure symptoms according to nyha functional classification
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Gastrointestinal Disease | Diarrhea | Vomiting
Item
patients who are gastrointestinal disorder (diarrhea, vomiting)
boolean
C0017178 (UMLS CUI [1])
C0011991 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
Complications of Diabetes Mellitus Serious
Item
patients with serious diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Alcohol addiction Excessive
Item
patients who are the excessive alcohol addicts
boolean
C0001973 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
Liver disease Severe | Kidney Disease Severe
Item
patients with severe hepatic disorder or severe renal disorder
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unable
Item
patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
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